The rights and interests of the U.S. Provisional Application that the application requires to submit on JIUYUE 13rd, 2006 U.S. Provisional Application is submitted to number on May 4th, 60/825,529 and 2007 number 60/916,110, the two all includes this description by reference in.
The specific embodiment
The invention provides a kind of vascular treatment device, comprising:
A handle, this handle has:
A motor;
One is triggered part, and this triggering part is installed on this handle and is connected at one first state that this electric electromechanics is not connected to a power supply and with this motor between one second state of this power supply convertible; And
A male connector, this male connector is rotatably driven by this motor; And
A cover box, this cover box can engage and have with this handle:
A cloudy connector, the size and dimension of this moon connector are suitable for can being engaged by this male connector, and in case engage promptly by this male connector rotation;
Single line silk, this filament have a near-end that is fixed on this moon connector, a main shaft, and this main shaft is from this proximal extension and end at a far-end; And
A sheath, this sheath are fixed to this cover box and from its extension, this sheath limits a tube chamber, and this filament passes this tube chamber and extends;
Wherein when this moon connector does not engage with this male connector, this sheath covers the far-end of this filament, and wherein when this moon connector engages with this male connector, this sheath does not cover the far-end of this filament.
The present invention also provides a kind of handle, comprising:
A motor;
One is triggered part, and this triggering part is installed on this handle and is connected at one first state that this electric electromechanics is not connected to a power supply and with this motor between one second state of this power supply convertible; And
A male connector, this male connector is rotatably driven by this motor;
Wherein one or more parts of this handle limit one and trigger ring; This triggering part part at least is placed in this triggering ring; And wherein this handle is arranged to, when only this triggers one or more parts of ring when supported from the qualification of this handle, this handle is equilibrated.
The present invention provides a kind of filament that uses with vascular treatment device again, and this filament comprises:
A near-end:
A far-end; And
A main shaft that between the two, extends;
Wherein:
This far-end is to be comprised by nearly extremely order far away: one first section, one second section and one the 3rd section;
This first section is extended and is biased to one first angle, this first angle between this main shaft and this second section:
Be limited between this main shaft and this first section; And
Less than 180 degree;
This second section is extended and is biased to one second angle, this second angle between this first section and the 3rd section:
Be limited between this first section and second section; And
Less than 180 degree; And
The 3rd section extends to a free end and is biased to one the 3rd angle, the 3rd angle from this second section:
Be limited between this second section and the 3rd section; And
Less than 180 degree.
The present invention further provides a kind of vascular treatment device, comprising:
A handle, this handle has:
A motor;
A motor connector, this motor connector is rotatably driven by this motor;
One is triggered part, and it is convertible that this triggering part is installed on this handle and is connected at one first state that this electric electromechanics is not connected to a power supply and with this motor between one second state of this power supply; And
A kind of filament, this filament have a near-end that is fixed to this motor connector, a main shaft, and this main shaft is from this proximal extension and terminate in a far-end; And
Convertible between a cover box, this cover box primary importance and second position in this handle, this cover box has:
A sheath, this sheath are fixed to this cover box and from its extension, this sheath limits a tube chamber, and this filament passes this tube chamber and extends;
Wherein in this primary importance, the far-end of this filament is not exposed, and in this second position, the far-end of this filament is exposed.
Vascular treatment device can be used for excising the blood vessels such as vein of (ablate) such as varicose, is used for through softening (macerate) blood clot and injects thrombolytic medicine and treat thrombosis, and also have other purposes.Vascular treatment device can comprise a rotatable filament, and the size and dimension of this filament is suitable for excising blood vessel and this filament is connected to a cover box that can join a handle to.Therefore, filament can be indirectly with handle in an electric motor, when actuating motor, make the filament rotation like this.When this device is used to treat varicosis, the filament of rotation can the disturbance blood vessel producing vasospasm (a kind of blood vessel produces the state of contracture), and can produce blood vessel wall and destroy to promote sclerosis.In the process of thrombectomy, filament can soften blood clot and blood vessel wall not produced destruction.
Fig. 1 shows the embodiment of the assembly of avascular treatment device 10 with ahandle 12 and a cover box 14.As shown in the figure, the size and dimension ofcover box 14 can be suitable for joining on thehandle 12 through parts are installed to another parts.Fig. 3 illustrates in greater detail an embodiment of handle 12.This handle can limit a receivedblock 29, andmale connector 30 is positioned in this receivedblock 29 whencover box 14 engages withhandle 12, to receive thecloudy connector 40 of cover box 14.Handle 12 can comprise that amotor 22, onetrigger part 26 and a male connector 30.Male connector 30 can be connected tomotor 22 by this way, and promptly when starting, motor rotatably drives male connector.Apotentiometer 24 can be electrically connected to the speed ofmotor 22 with the control motor.Trigger thatpart 26 can be installed on the handle and convertible between one first state (electric electromechanics not being connected to power supply) and one second state (motor is connected to power supply).
Themicroswitch 28 thathandle 12 can also comprise apower supply 20 and be connected tomotor 22 through a wire 32.Microswitch 28 can be inserted in and connect among the circuit that triggerspart 26 and motor 22.Microswitch can be biased to an open position, and the circuit that triggers like this between part and the motor breaks off.Whencover box 14 engaged inhandle 12, the cover box can be oppressed microswitch, causes it to be transformed into a closure state, connected the circuit that triggerspart 26 andmotor 22 thereby connect.For example, microswitch can comprise two contacts that have conductor, and this conductor is attached to a contact and when microswitch is in off-state and second contact separation.In one embodiment, conductor can comprise a bonding jumper that is suspended in the passage, the cover box with process that handle engages in this passage, slide.When the cover box engaged in handle, it was released this passage with bonding jumper and it is connected with second contact of microswitch.An advantage that obtains from this configuration can be: user is ready to use this device before, that is, at cover beforebox 14 joinshandle 12 fully to, he can not trigger part and start this device unintentionally through pressing.
Handle 12 can also comprise aswitch 16 as shown in Figure 3.Switch 16 allowscover box 14 to be received and secured inhandle 12 by handle 12.Switch can comprise that agripping member 15 is to allow user with this switch of finger manipulation.Switch can also comprise adoor 17, and this door alternately stops according to its position or pins and overlap box.For example; User can be put into thumb on thegripping member 15 andpull switch 16leaves handle grip 25 so that (whereindoor 17 is positioned at the passage from a primary importance withswitch 16; Therefore prevent to overlap the joint ofbox 12 and handle 14) be transformed into a second position (whereindoor 17 shifts out from passage, from then on allows the joint of cover box and handle).When theswitch 16 that release is biased,door 17 can get in the complementary retainer in the cover box, from then on helps the maintainance set box to engage with handle.
Door 17 can be by being biased to primary importance with the contactedspring 23 of handle.Whenuser pull switch 16leaves handle grip 25,switch 16 will be pressed on the spring, thereby in case the user release-push, just generation forces switch to get back to a restoring force in its home position.
As stated,door 17 can further be switched to one the 3rd position, and the 3rd position prevents to overlapbox 14 and breaks away from from handle 12.For example, when the switch that is biased 16 when the second position turns back to its home position and is locked to handle will overlap box, candoor 17 be pressed in the retainer 35 (shown in Figure 4) that is limited incover box 14.
One or more parts ofhandle 12 can limit one and triggerring 18; Triggering part at least partly is placed in this triggering ring; Handle is arranged to around this triggerings ring, and when only when the qualification of handle triggers one or more this handle of parts support of ring, it is equilibrated.In this way, the user qualification that can be simply props up handle with a finger (for example forefinger) part thattriggers ring 18 supports this handle and makes its balance.Becausemotor 22 is likely parts the heaviest in the handle; As shown in Figure 3; Can it be positioned at the below of triggeringpart 26, be applied to through the bending moment on the finger that triggers the ring support handle to reduce bymotor 22, thus the fatigue of minimizing user impression.
Handle 12 can form through two outer casing members are linked together.
Fig. 4 shows an embodiment of thecover box 14 shown in Fig. 1 in furtherdetail.Cover box 14 can comprise acloudy connector 40, single line silk 33 (being expressed as a dotted line) and be fixed to coverbox 14 and from asheath 32 of its extension.Filament can be fixed on thecloudy connector 40; For example the near-end of filament can crooked about 90 degree in case assembling through a passage, the size and dimension of this passage is suitable for receiving the end of the bending of this filament.Incloudy connector 40, can receive a hold-down screw and/or can use a kind of suitable binding agent to fix filament and prevent that it from rotating with respect to cloudy connector.
Sheath 32 can limit a tube chamber, andfilament 33 passes this tube chamber andextends.Sheath 32 can have the interior external diameter of wide region.In some embodiments, the internal diameter of sheath can be in 0.022 inch to 0.048 inch scope.In some embodiments, the external diameter of sheath can be in 0.025 inch to 0.051 inch scope.The external diameter of sheath can also with the corresponding to scope of the standard needle with corresponding internal diameter in.For example; The size and dimension of sheath can be suitable for being inserted in a standard needle or the vascular sheath, the scope of the internal diameter of said standard needle or vascular sheath be from 0.0035 inch to 0.1060 inch, or from 0.0160 inch to 0.0420 inch, or from 0.0420 inch to 0.0630, or from 0.0115 inch to 0.0630 inch.The maximum outside diameter of this sheath can less than 0.035 inch to allow sheath to be inserted into to pass an internal diameter less than 0.0039 inch venous needle or conduit, the practitioner of wide region implements operation thereby allow more.External diameter greater than 0.079 inch (6French, Fr) or the syringe needle of 0.092 inch (7Fr), conduit or vascular sheath need insert by vascular surgery doctor or intervention radiation doctor usually.
Sheath 32 can also comprise a plurality of external labeies that are in fixed interval, and these labellings can instruct the insertion ofuser determinator 10 or extract speed.
The exemplary of reservoir that description can be connected to the cover box can comprise asyringe 44, acock 46 and aplunger 48, and is as shown in Figure 5.Syringe 44 can be in that fluid is communicated with so that at the wire distal ends h substance with the hole ofsheath 32; For example sclerosing agent (example comprises polidocanol, sodium tetradecyl sulfate and hypertonic saline) or thrombolytics (example comprise alteplase (Activase), anistreplase (Eminase), streptokinase (Streptase, Kabikinase), urokinase (Abbokinase) and tissue plasminogen activator (TPA).In this way, the physical perturbation that is caused by filament can combine with Drug therapy to improve the device effect synergistically.
Handle 12 can comprise a support member 19 (being shown among Fig. 3), and it is positioned as and receives syringe 44.The size and dimension ofsupport member 19 can be suitable for compatible mutually with standard syringe and can prevent that syringe from coming off in injection process, if especially the material of injection has high power capacity with/viscosity and require the thumb of user on syringe, to apply bigger pressure.When thecover box 14 that has attachedsyringe 44 joined handle to,syringe 44 can snap fitted on the support member 19.As shown in Figure 1, support member can be formed by two carriages that frame is lived syringe.An alternate embodiment shown in Fig. 6 and 7 comprises a support member that is formed around a single hook spare of syringe by part.These embodiments allow to use this device according to the preference and/or the position of patient on treatment table of user with the right hand and with left hand.
Size, shape and the position ofhandle 12 andsyringe 44 can be suitable for allowing user to start triggeringpart 26 and with the thumb of the same hand aplunger 48 is oppressed the entering syringes simultaneously with the forefinger of a hands, allows infilament 33 rotations, to pass through sheath from syringe administering therapeutic medicine.For example, a user can hold handle like this, promptly; Handlegrip 25 is placed palm central authorities, make the thorny handle gripping member of the 3rd, the 4th, the 5th Ring put around finger for massage of cavity of human body, forefinger is passedtrigger ring 18; And if necessary, make the thumb depresses plunger get into syringe to discharge medicine.Handle can be designed as and allows dexterous and left-handed user all can operate.
Cock 46 shown in Figure 5 can allow to install additional again the fluid concentrations of fluid and permission change compositions and the sclerosing agent fluid is mixed with gas.For example, can mixing air, be used to produce foam, and be used to stir existing sclerosing agent/admixture of gas and produce foam again, because foam has one period limited persistent period before fluid and gas begin to separate (typically being one minute or shorter).Cock 46 can allow the convection cell mixture to stir, and will perhaps not need not shut down procedure from the separation of cover box by syringe.
The Y of a standard as shown in Figure 4 hemostasis joint 34, perhaps other Y hemostasis joints can be used to helpsyringe 44 to be communicated with fluid between the tube chamber that is limited sheath 32.Y hemostasis joint 34 can be connected to female Luer needle stand (luer hub) 31 and be connected topipe nut 36 in case fluid is leaked in the zone that comprises motor 22.Can use a kind of O type ring to prevent in the axial leakage of filament.The size and dimension offilament pipeline 42 can be suitable for receivingfilament 33 and be attached on the cloudy connector 40.The combination of above-mentioned parts can allow motor to rotate filament, and needn't increase the moment of torsion that exceeds suitable working range.Motor can rotate in the scope of from 500 to 3000 rev/mins or 4000 rev/mins to be used for the broken ring of varicosis and treat with thrombectomby.Handle can also comprise lets a built-in RPM display of user reading speed perhaps can comprise an electric port, can come measuring speed by an external monitoring device through this electricity port.
Male connector 30 on thehandle 12 can be biased towards an expansion state and can be transformed into a contraction state from this expansion state.The size and dimension ofcloudy connector 40 can be suitable in the engaging process ofhandle 12 andcover box 14male connector 30 is turned to contraction state from expansion state.Whenmale connector 30 andcloudy connector 40 were bonded with each other fully, the retainer that male connector has moved cloudy connector slided in the cover box to allow cloudy connector.
Therebycloudy connector 40 andmale connector 30 attachedcauses sheath 32 to slide backward with respect to filament.The generation of this action is because sheath is fixed to the cover box, and the fixing Zhiyin connector of filament.When the cover box was arranged in handle fully, cloudy connector was pushed forward in the cover box.So whencloudy connector 40 did not engage withmale connector 30,sheath 32 can cover the far-end offilament 33, allowed it to get into patient's vascular system safely; And whencloudy connector 40 engaged withmale connector 30, sheath can come out the distal end exposed of filament.Therefore, when the yin and yang lian fitting engaged, the far-end of filament just came out, and (2) filament passes the yin and yang lian fitting and is operably connected on themotor 22 to allow motor to rotate filament 33.As stated, the cover box can also unclamp a lever arm being connected to microswitch 28 to connect the circuit that triggers betweenpart 26 and the motor 22.In case the size and dimension ofmale connector 30 can be suitable for just turning back to whencover box 14 engages withhandle 12 as previously mentioned fully expansion state.
If when will be when filament be moved in the use location, or TD, cloudy connector can break away from so that cover the far-end of filament again with maleconnector.Make filament 33 slide from the male connector disengaging cloudy connector with respect to sheath 32 (it is attached to the cover box that is fixed to handle); The result is that the far-end of filament no longer exposes, and allows to move safely it.This mechanism can be protected the end offilament 33 and in the process that moves and reorientate of device, also protect blood vessel and other bodily tissues before using.
Male connector 30 can have at least two tips being separated by the part of splitting so that be transformed into contraction state from expansion state.Male connector can by Merlon, plastics, or the other materials that allows between expansion state and contraction state, to change process.
In some embodiments,vascular treatment device 10 can be single a structure with a handle and a cover box.The cover box can be assembled into handle in the process of making, and can in handle, between a primary importance (not engaging in this primary importance middle-jiao yang, function of the spleen and stomach and cloudy connector) and a second position (engaging in this second position middle-jiao yang, function of the spleen and stomach and cloudy connector), change.An embodiment of this type device can allow to overlap box and in the groove that handle limited, in a preset range, slide before and after (for example in this first and second position), but cover box itself cannot break away from handle.Sheath can be fixed to cover box and from its extension, and limits a tube chamber, and filament passes this tube chamber and extends.The cover box can also comprise by a syringe that support member received that is installed on the handle.
In this embodiment, handle can comprise a motor, a motor connector, a triggering part and a power supply.Filament (near-end that it has a main shaft, a far-end and is fixed to the motor connector) can be attached to the motor connector.The motor connector can rotatably be driven by motor.Trigger that part can be installed on the handle and convertible between one first state (this state is not connected to power supply with electric electromechanics) and one second state (this state is connected to power supply with electric electromechanics).Handle can also comprise that a microswitch is electrically connected to allow triggering part and motor each other.
In primary importance, the cover box can cover the far-end of filament.In the second position, cover box (1) comes out the far-end of filament from sheath, and the circuit that triggers between part and the motor is connected through unclamping the lever arm that is connected to microswitch in (2).Therefore, the vascular treatment device of single structure can allow user to obtain with explained before and be shown in similar functional of device among Fig. 1.
Fig. 6 shows another embodiment of vascular treatment device 10.Handle can have asupport member 19 that is used forsyringe 46, and this support member is aforesaid hook spare form.As shown in Figure 7, this embodiment can be assembled through two housings are complementary.Syringe can be installed on the support member and in the device use and remain on original position.Support member 19 (and/or handle 12) can be processed by the SLA resin or by the other materials that allows support member to bear the clamping force that syringe applies.
Fig. 8 shows the vertical view of end of an alternate embodiment ofhandle 12, and this handle has cover box 14 (not shown) are remained to a recess 80 on the handle 12.In the mentioned in front embodiment, handle has a switch that can be connected to a door, and this goalkeeper overlaps box and remains to handle.In this configuration, recess 80 can prevent that overlapping box breaks away from from handle.In use, user can slip into the cover box handle and will overlap box then and " buckle " to advance in the otch 80 to prevent overlapping box from the handle slippage.
Can use the wire distal ends of numerous types.Fig. 9 to 11, Figure 14 to 14A, Figure 15 to 15A, Figure 16 to 16A, Figure 17 to 17A, Figure 18 to 18A, Figure 19 to 19A, Figure 20 to 20A, Figure 21 to 21A, Figure 22 to 22A, Figure 23 and Figure 24 show several instances.
Fig. 9 shows an embodiment offilament 33, and it has a near-end 50, a far-end 52, and this far-end is to comprise onefirst section 54, onesecond section 56 and one the3rd section 58 by near to order far away.Can betweenmain shaft 51 andsecond section 56, extend forfirst section 54 and can be biased to one first angle, this first angle is limited betweenmain shaft 51 andfirst section 54 and less than 180 degree.Can betweenfirst section 54 and the3rd section 58, extend forsecond section 56 and can be biased to one second angle β, this second angle is limited betweenfirst section 54 andsecond sections 56 and less than 180 degree.Can extend to a free end and can be biased to one the 3rd angle γ fromsecond section 56 for the3rd section 58, the 3rd angle is limited betweensecond section 56 and the3rd section 58 and less than 180 degree.
Second angle can be greater than first angle.First angle and the 3rd angle sum deduct second angle can be at about 70 degree to the scope of about 110 degree.First angle and the 3rd angle sum deduct second angle can be at about 80 degree to the scope of about 100 degree.First angle and the 3rd angle sum deduct second angle can be about 90 degree.
The3rd section 58 length offilament 33 can be less than the internal diameter of sheath 32.For example, the3rd section 58 length can be equal to or less than less than the length of 0.028 inch or itsheath 32 internal diameter 2/3.
Can be less than 0.3 inch from the central axis ofmain shaft 51 to the measured vertical dimension of free end.First section 54 andsecond sections 56 length separately can about 0.2 inch to about 0.3 inch scope, perhaps about 0.24 inch to about 0.26 inchscope.First section 54 length can about 0.248 inch to about 0.25 inch scope, and second section length be about 0.25 inch to about 0.252 inch scope.In one embodiment,first section 54 length can be 0.249 inch, and second section length is 0.2504 inch.
The far-end 52 offilament 33 can comprise at least two linearity ranges, their relative to each other directed angles that is in a non-zero.Have at least two linearity ranges and can allow the far-end of filament to fill in sheath and do not contact the wall of sheath, and it can also allow the main shaft of filament to extend along blood vessel wall, and the end of filament (for example the 3rd section) thrusts blood vessel wall.
According to the purposes of expection, be positioned at the configuration that the filament end of far-end 52 can have numerous kinds.Wire shape can be " atraumatic ", and the meaning is that its shape can be adapted such that insert action causes the very little spasm that perhaps do not cause perhaps to damage to blood vessel.For example, Figure 10 shows the far-end 52 that stops with a hemispherical free end.This hemispheric end can be veined or mechanically or chemically changed to produce rough surface.Other atraumatic ends can comprise have the full circle arc, or bend to J-shaped, or only be the end of a curved shape.
Figure 10 shows an atraumatic end, and this end has alongfilament 33 from hemispherical shape a sleeve pipe to the proximal extension offilament.Sleeve pipe 70 can be gained in strength for far-end, thereby increases scraping power and increase contact surface long-pending to prevent the disengaging ofhemispheric end 72.
In other embodiments, far-end 52 can be " aggressive " and by bending or warpage so that its scraping blood vessel wall.Fig. 9 shows has flat free-ended far-end 52, has sharp edges around this free end.Can also be through the edge bevel be constituted an aggressive far-end 52 to constitute cusp.Far-end with cutting blade (wing as shark is the same) also can be aggressive.Far-end 52 can carry out roughened, cuts and/or cause blood vessel wall generation spasm so that far-end has more aggressivity ground.
Coarse surface can form through abrasion, machined, sandblast, for example acid corrosion of chemical attack (for example nitric acid, Fluohydric acid., hydrochloric acid and/or sulphuric acid) through the steel that make otherwise smooth.Coarse outer surface can also produce to produce surface irregularity through rolled metal plate (for example forming the plate of sleeve pipe 70) on the guide member that is shaped brokenly at.
The outer surface of first section equally,, second section and/or the 3rd section can apply a kind of grinding agent so that rough surface.Other surface treatments can comprise coarse file type and diamond grit.For example, the diamond of No. 30 granularities can produce aggressive surface, and the diamond of No. 200 granularities can produce non-attacking surface.
In use, the filament that especially has a roughened tip can periodically be wrapped in the sheath to help to remove from the filament end the normal operation of chip and holding device again.
Spiral shell tooth through deferring to difformity (for example square, rhomboid, trapezoidal, parallelogram, ellipse, triangle or pentagon) is introduced a thread contour with one second filament along the length offilament 33, and it is surperficial onfirst section 54 and/orsecond sections 56 offilament 33, to form a kind of aggressivity.
Figure 10 shows an embodiment, and it has onefirst section 56, and this first section has asleeve pipe 70, and this sleeve pipe has a coarse outer surface that is produced with one of mentioned distinct methods in front.Except showing roughened surface treatment, Figure 10 has further showed the single line silk that has increased weight at far-end, and this weight is to be increased by the sleeve pipe that has rough external surface in this situation.This weight can concentrate on the filament or eccentric location.An eccentric weight can be so that filament swing everywhere in rotary course.Compare with the filament that increase the weight of at the center, this swing effect can have more aggressivity ground disturbance blood vessel.
The far-end 52 offilament 33 can also comprise a bending section.The curvature of this bending section can be constant, and perhaps it can defer to other curves, and is for example oval or avette one section.The far-end 52 offilament 33 can also have a straight section in this bending section distally.Be similar to the embodiment with constant curvature, the curvature that has this bending section of straight section can be constant, and perhaps it can defer to aforesaid shape.
Spring 90 can carry out attached to produce an aggressive cutting surface alongfirst section 54 and/orsecond sections 56 from the far-end 52 of filament 33.Can carry out brazing in a plurality of ends to spring.Spring 90 can be deferred to aforesaid differently contoured.Figure 11 to 13 shows the cross sectional view of the spring of deferring to square, trapezoidal and pentagonal spiral shell tooth respectively.
The wedge angle of differently contoured (for example, square, triangle, parallelogram, pentagon) can thrust in the blood vessel wall and the excision blood vessel wall.According to the purposes of expection,filament 33 can have hemispheric or flat free end.Hemispheric end or flat free end can also be veined or roughened.